The burden is on the importer to overcome the appearance of a violation. Given the discretion afforded to FDA in the FDC Act over imports, we have no doubt that FDA will present myriad arguments that First Fishery’s case is without merit. We will be watching this case, as well as ...
The Court of Appeals cautioned that it was not suggesting that the Lanham Act can never support a claim involving FDA approval or clearance of drugs or medical devices. It stated that if a company makes “an affirmative statement of approval by the FDA was required before a given product cou...
Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, ofNorth Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film that is admin...
New public health threats Well need to be prepared to respond rapidly to unexpected health risks, such as the threat of terrorism, tougher strains of antibiotic-resistant bacteria or more dangerous foodborne illnesses. International commerce Monitoring of imports and cooperation with foreign regulators ...
The high cost of prescription drugs in the United States has prompted some consumers to seek medications from foreign sources. Current law permits only the manufacturer of a prescription drug to import it. Such importation is tightly regulated by FDA based on law. Because imports acquired outside...
The bill would also authorize FDA to establish science-based performance standards for classes of food, safety standards for fresh produce, a tracing system for domestic and imported food, a requirement for third party certification of imports, and safety and security guidelines for food imports. ...
Office for the District of Massachusetts issued astatementannouncing the charging of Doctor Scott Reuben, a former Chief of Acute Pain at Bay State Hospital in Springfield, Massachusetts, with one count of health care fraud (18 U.S.C. §1347), alleging that Dr. Reuben falsified medical ...